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Hepatitis C, ChronicPhase 2NCT02993250

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

A Phase 2 study testing AL-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Hepatitis C, Chronic, run by Janssen Pharmaceutical K.K. at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
AL-335, Odalasvir (ODV) and Simeprevir (SMV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
14 sitesJapan
Study dates
21 Dec 2016to 7 May 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic hepatitis C virus (HCV) infection
  • All participants must have HCV genotype 1 or 2 infection, determined at screening
  • HCV ribonucleic acid (RNA) plasma levels greater than or equal to (>=)10,000 international units per Milliliter (IU/mL), determined at screening
  • Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
  • Participants without cirrhosis or with compensated cirrhosis

Who cannot join

  • Infection with HCV genotype - 3, 4, 5, or 6
  • Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)
  • Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
  • Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
  • Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Study site

    Amagasaki-shi

  • Study site

    Bunkyō City

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Kurume-shi

  • Study site

    Musashino-shi

  • Study site

    Nagoya

  • Study site

    Omura-shi

  • Study site

    Osaka

  • Study site

    Saitama

  • Study site

    Sakaishi

  • Study site

    Sapporo

  • Study site

    Suita-shi

  • Study site

    Yokohama

Other trials in Japan

About this study

Official title: A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.

Being tested
AL-335, Odalasvir (ODV), Simeprevir (SMV)
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AL-335Drug

    Also called JNJ-64146212

    Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

  • Odalasvir (ODV)Drug

    Also called JNJ-64289901

    Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

  • Simeprevir (SMV)Drug

    Also called TMC435

    Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Study groups in NCT02993250
Study groupRoleWhat they receive
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)ExperimentalParticipants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)ExperimentalParticipants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
Receives: Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)

Secondary outcomes (7)

  1. Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment

    SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).

    Measured: Week 4 (follow-up phase)

  2. Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment

    SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.

    Measured: Week 12 (follow-up phase)

  3. Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment

    SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.

    Measured: Week 24 (follow-up phase)

  4. Percentage of Participants With Viral Relapse

    Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.

    Measured: End of treatment up to Week 24 (follow up phase)

  5. Percentage of Participants With On-treatment Failure

    On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.

    Measured: EOT up to Week 12 (follow up phase)

  6. Percentage of Participants With On-treatment Virologic Response

    Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.

    Measured: Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)

  7. Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ

    Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.

    Measured: EOT up to Week 24 (follow up phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study start21 Dec 2016
  3. Primary completion7 May 2018
  4. Study completion7 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993250
Sponsor's protocol ID
CR108264
Other IDs
64294178HPC2003
Status last verified
Sep 2019
First submitted
13 Dec 2016
Last updated
11 Sep 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AL-335, Odalasvir (ODV) and Simeprevir (SMV) in people with Hepatitis C, Chronic, run by Janssen Pharmaceutical K.K. at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.

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